Targeted biopsy delivery system

ABSTRACT

This invention relates generally to the targeting and biopsy of tissue for medical purposes, and more particularly to a targeted biopsy system which allows planning of tissue to be sampled, targeting of specific areas of tissue in reference to the plan, capturing the tissue sample and recording the source location of the tissue sample, particularly for use in collecting tissue samples from the prostate gland. A further purpose of this invention is to provide a targeted treatment system which allows planning of tissue to be treated, targeting of specific areas of tissue in reference to the plan, and delivering the treatment to the targeted tissue.

CROSS REFERENCE TO RELATED APPLICATION

This nonprovisional patent application claims priority to theprovisional patent application having Ser. No. 60/494,910, which wasfiled on Aug. 13, 2003.

BACKGROUND OF THE INVENTION

Prostate health is a significant concern for men over the age of fifty.If prostate cancer is suspected from either a physical examination orbecause of a Prostate Specific Antigens test, a biopsy is performed tocollect tissue samples from the prostate for evaluation by apathologist. Prostate tumors are small growths scattered about theprostate. For this reason, a physician will take multiple tissue samplesfrom different areas of the prostate, typically between 9 and 18samples.

The normal procedure for obtaining biopsy samples with ultrasoundguidance is called Transrectal Ultrasound (TRUS) Guided Prostate Biopsy.An end-fire ultrasound probe is used, which generates a pie-shaped imageplane. Some end-fire probes are manufactured with a biopsy needlechannel, which passes through the body of the probe at an angle, suchthat a biopsy needle set inserted through the biopsy needle channelexits the channel at a slight angle relative to the body of the probe.Most probes require a needle set guide tube to be affixed to the probebody, such that a needle set placed through the guide tube parallels theaxis of the probe and the needle set can be extended beyond the end ofthe probe. In use for both, the physician inserts the ultrasound probeinto the rectum, and moves the probe around until the specific area ofthe prostate to be sampled is identified. The physician then bends theprobe upward, pointing the biopsy needle channel or biopsy needle setguide at the targeted area of the prostate. A needle set is insertedinto and through the needle channel or guide, pushed through the rectumwall and into the prostate.

Standard coring biopsy needles sets are made from substantially rigid,coaxially aligned, stainless steel wire and tubing. They are comprisedof two basic components; an inner solid wire stylet with specimen notchand a hollow outer cutting cannula. Once the needle set is correctlypositioned relative to the area of tissue to be sampled, the innerstylet is quickly advanced under spring loaded or similar pressure intothe prostate tissue. The tissue to be sampled then “prolapses” intostylet's sample notch cutout. Almost instantaneously the outer cuttingcannula quickly advances, also under spring loaded pressure, whichserves to sever and capture the tissue that had prolapsed into thestylet notch. The needle set is then removed from the tissue/patient sothat the tissue sample can be extracted from the needle set andevaluated for the presence of cancer. The physician then moves the probearound within the rectum to identify the next area of the prostate to besampled, and the process is repeated. As noted, between 9 and 18 samplesare typically taken from different areas of the prostate.

Existing biopsy methods suffer from a number of disadvantages. Becausethe probe must be physically moved about within the rectum by hand toidentify and target the different areas of the prostate, it is difficultfor physicians to precisely targeted biopsy sample locations, oftencausing the need for additional samples to be taken. Further, if asample seems to confirm cancer, it is difficult for the physician toaccurately know where in the prostate the sample was taken from, and sodifficult to re-biopsy the same tissue location to confirm the cancer.

A number of systems or devices have been proposed for the purpose ofbetter targeting biopsies. Batten, et al, (U.S. Pat. No. 5,398,690)discloses a slaved biopsy device, analysis apparatus, and process. InBatten, an ultrasound device is inserted into the male urinary tractthrough the penis, with the biopsy and treatment device insertedtransrectally. Chin, et al, (U.S. Pat. No. 6,179,249) discloses anultrasound guided therapeutic and diagnostic device. Chin is a flexibleultrasound device used for laproscopic surgery. Lin (U.S. Pat. No.6,261,234) disclosed a method and apparatus for ultrasound imaging withbiplane instrument guidance. Lin's ultrasound device uses twotransducers to create two image planes, and has a biopsy needle guidewhich directs a biopsy needle at the intersection of the imaging planes.Burney, et al (U.S. Pat. No. 6,447,477) discloses surgical andpharmaceutical site access guide and methods. Burney shows a biopsydevice in which a thick needle with side exit ports is inserted into thetargeted tissue. Biopsy needles are then inserted into the thick needle,exiting out the side to take samples. Further, a number of systems havespecified the use of flexible biopsy needle kits.

However, all of these inventions suffer from a number of disadvantages.All require specialized equipment, and do not make use of existingultrasound systems and technology. All require the movement of theimaging device, making it more difficult to plan and target areas of theprostate for biopsy. Further, the flexible biopsy needles called outeither require heating or additional force to cause them to fire, andare impractical for use with established prostate biopsy procedures andexisting biopsy needle set firing devices.

Therefore, users would benefit from a biopsy system to allow a biopsy tobe planned prior to the tissue sampling, to allow the biopsy needle tobe precisely inserted into a targeted area and which is able to recordthe precise location from which the tissue sample is collected while theimaging device remains stationary. Users would also benefit from aflexible needle set which may be easily “fired” while in a curvedposition. Further, users would benefit from a means of preciselydelivering a treatment to a targeted area of an organ or tissue mass.

SUMMARY OF THE INVENTION

It is the principal object of this invention to provide a device andmethod for precisely planning, undertaking and recording a multi-samplebiopsy of a targeted tissue mass such as a prostate, improvingphysicians' ability to diagnose cancer.

Another object of the invention is to allow a biopsy plan to beformulated identifying the specific quadrants and areas of the prostateto be sampled.

Another object of the invention is to allow this biopsy plan to be savedas a reference point.

Another object of the invention is to allow a physician to adjust thebiopsy needle guide to allow the physician to precisely insert theneedle into the tissue at the planned location.

Another object of the invention is to allow a physician to monitor theneedle set as it is inserted into the tissue, to verify that the needleis in the planned location.

Another object of the invention is to provide a biopsy needle guidewhich can be affixed to or associated with existing side-imagingtransrectal ultrasound probes.

A further object of the invention is to allow the transrectal ultrasoundprobe to remain stationary while the biopsy samples are gathered fromdifferent areas of the prostate, thereby improving the accuracy of theprocedure.

A further object of the invention is to allow the probe to remainstationary while the needle guide is moved longitudinally along theprobe and is also rotated around the probe.

A further object of the invention is to provide a needle set guide whichcan redirect the needle set such that the needle set can be curved whilestill maintaining the freedom of movement to allow the firing andcollecting of tissue samples.

A further object of the invention is to provide a biopsy needle set thatmay be redirected at an angle and further maintains its ability to befired and so collect the tissue samples.

An object of an alternative embodiment of the invention is to allow atreatment plan to be formulated identifying the specific areas of tissueor an organ to be treated.

A further object of an alternative embodiment of the invention is toallow this treatment plan to be saved as a reference point.

Another object of an alternative embodiment of the invention is to allowa physician to precisely insert a needle or treatment delivery meansinto the tissue at the planned location.

Another object of the invention is to allow a physician to monitor theneedle or treatment delivery method as it is inserted into the tissue,to verify that the needle or treatment delivery method is in the plannedlocation.

These and other objects, advantages and features are accomplishedaccording to the devices and methods of the following description of thepreferred embodiment of the invention.

SUMMARY OF THE INVENTION

As noted the present invention relates to a biopsy targeting system foruse with ultrasound imaging devices, and particularly for use insampling prostate tissue. The biopsy targeting system consists of aredirecting biopsy needle guide which works in conjunction with aside-view or end-fire transrectal ultrasound probe, a cooperatingsoftware program which can be loaded and operated on a computercontrolled ultrasound system, and a bendable needle set.

In use, the transrectal ultrasound probe is placed in the cradle of astabilizer. The redirecting needle guide positioning assembly is alsoaffixed to the cradle. The physician then advances and adjusts thecradle to allow the transrectal probe to be inserted into the rectum ofa patient. The physician generates an ultrasound image while positioningthe probe to insure that the patient's prostate is viewable within theviewing area of the probe. Once the probe is correctly positioned, thephysician then locks the probe in place in the stabilizer.

With the transectal probe in place, the physician initiates a full 3Dscan of the prostate. The multiple image slices are captured by theultrasound system. The physician then looks through these saved images,to identify possible problem areas of the prostate and further to decidewhich areas of the prostate to sample. Typically, physicians collect 9to 18 tissue samples from different areas of the prostate. As part ofthis process, the physician is able to use the software program toproject potential needle path lines onto the images of the prostate.These paths are shown as lines in views parallel to the needle path andas circles where the paths pierce the image plane. Each possible path isdescribed by the positional settings of the redirecting needle guide.When the physician identifies a specific area to be sampled, thephysician moves a projected needle path line to intersect the planedarea to be biopsied. The physician continues to evaluate the prostateand target additional areas for sampling, again saving projected needlepaths for each planned sample. Further, if the physician does notidentify any possible problem areas, but wishes to take a standardbiopsy, the physician can use a range of default setting on the computerprogram to project between 9 and 18 projected needle paths with astandard distribution throughout the prostate.

Once the biopsy is planned, the physician initiates the biopsy. All ofthe needle paths for a given longitudinal image are displayed on theultrasound monitor. The display shows the coordinates of the plannedneedle paths which correlate to the positional setting of theredirecting needle guide. The physician then advances and/or rotates theredirecting needle guide to the correlating coordinates for the firstplanned needle path. The physician then inserts a flexible biopsy needlekit into the redirecting needle guide's needle insertion point. Theneedle set is advanced by hand through the needle set channel, includingthrough the redirecting curve within the needle guide. This redirectingcurve causes the needle to exit the needle guide, within the rectum ofthe patient, at an angle relative to the transrectal probe. Thephysician pushes the needle guide through the tissue of the rectal walland into the prostate, monitoring the progress of the needle on theultrasound system and insuring that the actual path of the needlematches the planned needle path being projected on the image. When thebiopsy needle set has achieved the correct depth of penetration, thephysician uses a standard biopsy firing gun to “fire” the needle set,causing the stylet and cannula to quickly extend in sequence, cuttingand capturing a slice of prostate tissue in the specimen notch of theneedle set. Because the specimen notch is substantially longer than instandard biopsy needles and the cannula body is flexible, the needle setis very flexible and able to be fired even though bent. The specimennotch is extended to the curved portion of the needle set within theredirecting needle set guide, allowing the stylet to be quickly moved inreference to the cannula without binding. With the needle still in theprostate, the physician saves the ultrasound image(s) on the computerprogram, creating a permanent record of the biopsy tissue location. Thephysician then removes the biopsy needle with captured tissue sample.Once removed, the cannula is retracted from the stylet, allowing thetissue sample to be placed into a tissue specimen dish. The physicianthen advances or moves the redirecting biopsy needle guide to the nextplanned needle path location, and repeats the procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of targetable biopsy system in conjunctionwith an ultrasound imaging system and stabilizer.

FIG. 2 is a perspective view of the redirecting needle set guide mountedon a side-imaging transrectal ultrasound probe.

FIG. 3 is a side view of the redirecting needle set guide mounted on aside-imaging transrectal ultrasound probe, showing the guide positioningassembly.

FIG. 4 is a planning software interface displayed on the monitor.

FIG. 5 is a schematic of the biopsy planning process.

FIG. 6 is a schematic of the biopsy procedure.

FIG. 7 is a side view of an embodiment of the targetable biopsy guide.

FIG. 8 is a side cutaway view of an embodiment of the targetable biopsyguide designed to be manufactured with an insertable metal tube.

FIG. 9 is a side cutaway view of an alternative embodiment of thetargetable biopsy guide.

FIG. 10 is a side cutaway view of an alternative embodiment of thetargetable biopsy guide with an enlarged bend channel.

FIG. 11 shows a side view of a biopsy stylet with extended specimennotch.

FIG. 12 shows a side view of an alternative embodiment of the styletwith dual extended specimen notches.

FIG. 13 shows a side view of an alternative embodiment of the styletwith a tiered specimen notch.

FIG. 14 shows a side view of an alternative embodiment of the styletwith multiple notches to facilitate bending.

FIG. 15 shows a side view of an embodiment of the cannula in which thecannula tube has been ground down along its length to leave a flexiblespine.

FIG. 16 shows a side view of an embodiment of the cannula in which thecannula tube has been spiral-cut along its length to facilitate bendingof the cannula.

FIG. 17 shows a side view of an alternative embodiment of the cannula inwhich the tip of the cannula tube is uncut while the body of the cannulatube has been spiral-cut.

FIG. 18 shows a side view of an alternative embodiment of the cannula inwhich sections of the cannula tube alternate between cut and uncut.

FIG. 19 shows a side view of an embodiment of the cannula in which thecannula tube is encased in flexible tubing.

FIG. 20 shows a perspective view of an embodiment of the flexible needleset.

FIG. 21 is a side view of the traditional method of taking a prostatebiopsy with a biopsy needle channel.

FIG. 22 is a side view of the bendable needle and biopsy targetingsystem mounted on a side-fired probe taking a biopsy.

FIG. 23 is a side view of the redirecting guide with a flexible needleset inserted and extending out of the guide such that the needle set isbent by the needle set channel bend.

PARTS NUMBERS

-   Rectum 1-   Prostate 2-   redirecting guide 10-   alternative redirecting guide 10A-   positioning assembly 11-   targeting software system 12-   flexible needle set 13-   cradle 15-   stabilizer 16-   ultrasound system 17-   ultrasound system CPU 18-   side view transrectal probe 19-   monitor 20-   probe tip 22-   probe imaging window 23-   guide body 30-   needle set channel 31-   needle set insertion point 32-   needle set exit point 33-   front body guide extensions 34A, 34B-   imaging cutout 35-   needle set channel bend 36-   enlarged bend channel 37-   insertable metal tube 38-   rotational adjustment collar 40-   fixed collar 41-   longitudinal slides 42-   longitudinal position controller 43-   needle path location registry 50-   needle path lines 51-   needle path dots 52-   flexible stylet 60-   flexible cannula 61-   tip 62-   extended specimen notch 63-   stylet body 64-   cutting tip 65-   cannula body 66-   counter bore and taper 67-   bending notches 70-   tiered specimen notch 71-   segmented specimen notch 72-   removable needle set guide insert 75-   stylet hub 76-   cannula hub 77-   strip 78-   depth markings 79-   cannula sheath 81-   spiral cut 82-   non-spiral cut portion 83-   beveled edge 84-   Biopsy attachment angle selector 201 and display-   Biopsy attachment depth selector 202 and display-   needle path coordinates display 204 window-   Finished with Biopsy Planning 206 button-   Remove selected biopsy location 207 from plan button-   Add selected biopsy location to 208 plan button-   Select pre-planned template 209-   Sagittal image plane selector 210-   Transverse image plane selector 211-   Transverse image display 212-   Sagittal Image display 213

DESCRIPTION OF THE PREFERRED EMBODIMENT

As seen in FIG. 1, the targeted biopsy system is comprised of aredirecting guide 10, positioning assembly 11, targeting software system12 (loaded on CPU 18) and flexible needle set 13 (best seen in FIG. 20).The positioning assembly 11 is affixed to cradle 15, which is a part ofstepper and stabilizer 16. Working in conjunction with the targetedbiopsy system is ultrasound system 17, which is comprised of ultrasoundsystem CPU 18, side view transrectal probe 19 and monitor 20. Side viewtransrectal probe is comprised of probe tip 22 and probe imaging window23. As seen in FIGS. 2 and 7, the redirecting guide 10 consists of guidebody 30, needle set channel 31, needle set insertion point 32, andneedle set exit point 33, front body guide extensions 34A and 34B,imaging cutout 35. As seen in FIG. 10, needle set channel 31 may beprovided with enlarged bend channel 37. As seen in FIG. 8, theredirecting guide 10 may be provided with insertable metal tube 38. Inan alternative embodiment, the redirecting guide may contain one or morepathways may be used for insertion of the biopsy needle kit. Theredirecting guide may be comprised of a movable device such that theopening through which the needle kit exits may be moved relative to theopening into which the biopsy needle kit is placed. In a furtheralternative embodiment, the redirecting guide may straighten apreviously curved biopsy needle kit such that the biopsy needle kitre-curve when leaving the redirecting guide.

As best seen in FIG. 3, positioning assembly 11 is comprised ofrotational adjustment collar 40, fixed collar 41, longitudinal slides 42and longitudinal position controller 43.

As best seen in FIG. 4, targeting software system 12 is comprised oftransverse image display 212, Sagittal Image display 213, longitudinalprojected needle path 51 and transverse projected needle path 52, inaddition to various controls.

As best seen in FIG. 20 flexible needle set 13 consists of flexiblestylet 60 and flexible cannula 61. Stylet 60 may be affixed to stylethub 76, with cannula 61 affixed to cannula hub 77. Further, cannula 61may be provided with depth markings 79. As seen in FIG. 11, thepreferred Flexible stylet 60 consists of tip 62, extended specimen notch63 and stylet body 64. As seen in FIG. 12, an alternative preferredFlexible stylet 60 consists of tip 62 and segmented specimen notches 72a and 72 b. Alternative embodiments of flexible stylet 60, as seen inFIGS. 13 and 14, contain bending notches 70 and tiered specimen notch71.

As seen in FIG. 19, the preferred embodiment of cannula 61 consists ofcutting tip 65, cannula body 66 and cannula sheath 81. The cannulasheath may have beveled edges. As seen in FIG. 15, a portion of the bodyof flexible cannula 61 has been removed. As seen in FIG. 16, cannulabody 66 may be provided with spiral cut 82 to facilitate bending. Asseen in FIG. 17, in an alternative embodiment of cannula 61, cannulabody 66 may be provided with non-spiral cut portion 83 at cutting tip65, to facilitate the straight entry of the cannula into the tissue. Asseen in FIG. 18, in a further alternative embodiment of cannula 61,cannula body 66 may be provided with non-spiral cut portions 83interspersed with spiral cuts 82. In an alternative embodiment offlexible cannula 61 consists of a cutting tip inserted into the flexiblecannula body.

It should be noted that both the stylet cannula can be made from a rangeof flexible materials, including combinations of one or more materials,to facilitate the bendability. This may include traditional materialsused in medical devices, such as stainless steel, as well as materialssuch an nitinol®. Furthermore, the cannula design may mirror the stylet,such that portion or portions of the metal cannula tube are removed tocreate a metal component which has a metal cutting tip, a long spineconsisting of only a portion of the cannula wall in the flexible part ofthe cannula and then the full tubular cannula. Furthermore, the machinecannula may be partially or wholly incased in a cannula sheath, whichmay be plastic or some other material.

FIG. 21 shows a biopsy being performed using the standard method, usingan end-fire ultrasound probe with a biopsy needle channel. The probe isinserted into the rectum, and then angled upward until the probe tip ispointed at the desired portion of the prostate. A needle set is theninserted through the biopsy needle channel guide into the prostate 2.

In use of the preferred embodiment of the invention, as seen in FIGS. 1and 22, side view transrectal probe 19 is mounted on the cradle 15 of astabilizer 16. Redirecting guide 10 is also mounted on the cradle 15,such that guide body 30 sits atop probe tip 22. As seen in FIG. 2, frontbody extensions 34 a and 34 b partially wrap around probe tip 22 to helpmaintain the guide body 30 on the probe tip 22. The cradle 15 is movedforward, with the probe tip 22 inserted into patient's rectum 1. Probetip 22 is generating ultrasound images, which are displayed on monitor20. The physician uses this image to insure that the entirety ofprostate 2 is viewable by probe imaging window 23. Once the probe tip 22is correctly positioned, the physician locks in place cradle 15.

The biopsy planning process is illustrated in FIG. 5. A representativedisplay of the biopsy information to the user is shown in FIG. 4. Theprocess begins with the planning software obtaining a set of volumetricdata 101. The volumetric data consists of two sets of sampled images.One set is of longitudinal images sampled at a regular angular spacing,and the other is a set of transverse images sampled at regular depthspacing. If only one of the two sets is available, one may beinterpolated from the other. The physician starts the planning processby pressing button 203 to satisfy step 102 of FIG. 4. For 103, theplanning system overlays a series of lines 51 a, b, c, etc. and dots 52a, b, c, etc. on the images in panes 212 and 213. These lines and dotsrepresent the available needle paths selectable with controls 40 and 43,and show where the needle intersects with image planes. Each line anddot combination is labeled with a coordinate 50 corresponding to aunique pair of setting for controls 40 and 43. The user can review thestored images using controls 210 and 211 to change the image viewed. For104, the user can “simulate” the effect of controls 40 and 43 usingon-screen controls 201 and 202 to adjust the selected needle path. Thecurrent path is displayed by changing the color of the appropriate lineand dot (51 and 52, respectively). The user adds a specific needle pathto the biopsy plan (105) by selecting button 208. Each time a path isselected, a record is placed into needle path coordinates display window204 showing the coordinates of the path. The user may also remove aspecific path from the plan by selecting button 207. When the plan iscomplete, the user clicks on the button 206 to send the planning process(106).

Once the biopsy planning process has been completed, the physician ortechnician may then proceed with the biopsy procedure, to complete theseries of precision located biopsy's to be taken through the usage ofthis instrument. For example, as can be noted in FIG. 6, once a biopsyprocedure has been completed, the physician then determines whether anymore biopsies are needed, and where the biopsy locations may bedetermined. This can be seen at 301. If no additional biopsies arerequired, this is the end of the procedure. If additional biopsies areconsidered as needed, the physician then adjusts the redirection of theguide 10, and the longitudinal controller 40, to mass the desired biopsycoordinates, as provided upon the scanner. This can be noted at 302.Then, the user inserts a needle set 13 into the channel 32, to preparefor additional biopsies. The physician then inserts the needle into thepatient, moving the needle in and out to adjust for depth, as determinedby the scanner, as can be seen at 304. Then, the physician can determineif the needle tip is at the correct depth, at 305. If it is not, thenthe physician may move the needle and adjust its depth further. If itis, the physician then fires the needle of the biopsy instrument, as at306. Then the physician removes the needle set 13 from the patient,having taken the biopsy as required. Then, the tissue sample is removedfrom the biopsy needle notch, for further analysis by the lab. This canbe noted at 308. When this is completed, this concludes the conduct ofbiopsies upon the patient.

As alternative to the procedure in FIG. 4, preplanned biopsy selectionmenu 209 allows the user to select a pre-determined needle pattern,typically 9-12 needle paths, without having to select each needle pathmanually. The needle paths generated could need to be adjusted for thespecific size of the organ. The size of the organ can be input byvarious means. The planning process allows the physician to modify theneedle paths as needed and to approve that they are correct.

Projected needle paths 51 a, 51 b, etc, include needle path locationregistry 50, which indicate the horizontal and rotational position ofthe needle path in reference to the probe. Working from the saved biopsyplan, displayed in 204, the physician rotates redirecting guide 10 usingrotational adjustment collar 40, and then advances the redirecting guideusing longitudinal position controller 40, both of which have positioninformation which correlates to the needle path location registry 50. Asseen in FIG. 18, the physician inserts flexible needle set 13 intoneedle set insertion point 32 and into needle set channel 31. When theneedle set 13 reaches needle set channel bend 36, the needle set 13 isredirected at an angle away from the axis of probe tip 22. Needle set 13exits needle set exit point 33. Because of imaging cutout 35, thephysician is able to see the needle set in the ultrasound image as itexits exit point 33, allowing the physician to insure that the needleset 13 is in the path marked by projected needle path 51 a. Thephysician monitors the depth of the needle set 13 as it is pushedthrough the rectum wall and into the prostate 2. Once the desired depthis reached, the physician stops inserting the needle set 13. Using astandard biopsy gun, the needle set 13 is “fired”. This causes flexiblestylet 60 to rapidly advance a short distance, such that tissue from theprostate two prolapses into extended specimen notch 63. Almostinstantaneously flexible cannula 61 quickly advances, also under springloaded pressure or other motivational means, which serves to sever andcapture the tissue that had prolapsed into the extended specimen notch63. Because the extended specimen notch 63 extends to the point whereflexible needle set 13 is bent in needle set channel bend, the styletand cannula are able to fire without the two pieces binding together,allowing the specimen to be effectively captured. The physician thenremoves the flexible needle set 13 with the captured specimen. Thespecimen is removed from the flexible needle set, and the physician thenresets the redirecting guide to the coordinates of the next savedprojected needle path 51 b. The process is repeated until the physicianhas captured all of the samples as planned using the targeting softwaresystem 12.

FIG. 23 provides a side cut-away view of the redirecting guide with aflexible needle set inserted and extending out of the guide such thatthe extended specimen notch is bent by the needle set channel bend.

In an alternative embodiment of the invention, the invention is used toplan and perform a targeted treatment of an organ or tissue mass. Withthe device in place, the process begins with the planning softwareobtaining a set of volumetric data. The planning system overlays aseries of needle path lines and needle path dots on the images in panes212 and 213, which represent the available needle paths with coordinatesthat match the coordinates on rotational adjustment collar 40 andlongitudinal position controller 43 of positioning assembly 11. The userselects specific needle paths, which are saved the treatment plan.Preplanned treatment selections allow the user to select apre-determined needle pattern without having to select each needle pathmanually.

Working from the saved treatment plan, the physician rotates redirectingguide using rotational adjustment collar, and then advances theredirecting guide using longitudinal position controller, both of whichhave position information which correlates to the needle path locationregistry. The physician then inserts a flexible needle set or treatmentdelivery means into needle set insertion point 32 and into needle setchannel 31. When the needle set or treatment delivery means reaches theneedle set channel bend, the needle set or treatment delivery method isredirected at an angle away from the axis of probe tip 22. Needle set 13exits needle set exit point 33. Because of imaging cutout 35, thephysician is able to see the needle set or treatment delivery method inthe ultrasound image as it exits exit point 33. The physician monitorsthe depth of the needle set or treatment delivery method as it is pushedinto the targeted organ or tissue mass. Once the desired depth isreached, the physician is able to undertake the preferred activity. Thismay include using the delivery means to inject a solid, gas or liquidmaterial or other treatment apparatus into the targeted organ or tissuemass. Further, the physician may insert an organism into the targetedorgan or tissue mass. The material may be deposited and left in thetargeted organ or tissue mass. Further, material previously depositedmay be removed. The use of the deposited material may be as a treatment,a marker, or other uses. Further, the delivery means may be used toapply energy to a targeted organ or tissue mass, including but notlimited to heat, cold, light and radiation. Once the treatment ormarking is delivered, the physician then removes the flexible needle setor treatment delivery method, and then resets the redirecting guide tothe coordinates of the next saved projected needle path. The physicianhas the option of saving the image of the treatment needle in thetargeted organ or tissue mass, to record the location of the treatmentas delivered. The process is repeated until the physician has treated ormarked all of the targeted areas of the organ or tissue mass.

1. A targetable biopsy system comprising: a flexible biopsy needle kit;a redirecting biopsy needle guide; an imaging means; a biopsy planningand recording means; such that a specific area of tissue may beaccurately targeted for tissue collection.
 2. The device of claim 1whereby said flexible biopsy kit is comprised of: a flexible styletcontaining an extended specimen notch; a flexible cannula;
 3. The deviceof claim 1 whereby said stylet and said cannula are manufactured with apre-formed curve
 4. The device of claim 1 whereby said stylet and saidcannula are manufactured from flexible material such as nitinol® orplastic.
 5. The device of claim 1 whereby said stylet and said cannulaare manufactured without a pre-formed curve.
 6. The device of claim 1whereby said stylet is assembled from two or more sections each made ofmaterials with different properties to improve the flexibility.
 7. Thedevice of claim 1 whereby said cannula is assembled from two or moresections each made of materials with different properties to improve theflexibility.
 8. The device of claim 1 whereby the length of saidspecimen notch is increased to improve the flexibility of the stylet. 9.The device of claim 1 whereby multiple specimen notches are used toimprove the flexibility of the stylet.
 10. The device of claim 1 wherebythe depth of the specimen notches varies to improve the flexibility ofthe stylet.
 11. The device of claim 1 whereby said redirecting biopsyneedle guide is comprised of: an opening into which a biopsy needle kitmay be inserted; an opening through which a portion of the biopsy needlekit exits; a means of redirecting said biopsy needle kit such that theportion of the biopsy needle kit which has exited the biopsy needleguide is angled relative to the portion of said biopsy needle kit whichhas not been inserted into said biopsy needle guide. a means ofpositioning the redirecting biopsy needle guide relative to anultrasound imaging device which remains fixed.
 12. The device of claim 1whereby said means of redirecting the biopsy needle physically bends apreviously straight biopsy needle kit.
 13. The device of claim 1 wherebysaid means of redirecting straightens a previously curved biopsy needlekit such that the biopsy needle kit re-curve when leaving theredirecting means.
 14. The device of claim 1 whereby said means ofredirecting is comprised of one or more static angled or curvedchannels.
 15. The device of claim 1 whereby said means of redirectingstraightens is comprised of a movable device such that the openingthrough which the needle kit exits may be moved relative to the openinginto which the biopsy needle kit is placed.
 16. The device of claim 1whereby said redirecting biopsy needle guide is affixed to or associatedwith an ultrasound or imaging system.
 17. The device of claim 1 wherebysaid redirecting biopsy needle guide may selectively positioned orrotated relative to the imaging portion of the imaging means.
 18. Thedevice of claim 1 whereby said redirecting biopsy needle guide isprovided with demarcations or other indications of position relative tothe imaging portion of the imaging means.
 19. The device of claim 1whereby said imaging means records the position of the biopsy sample.20. The device of claim 1 whereby said imaging means may include abiopsy plan specifying the preferred locations of the biopsies relativeto the position of the imaging portion of the imaging means.
 21. Thedevice of claim 1 whereby said redirecting biopsy needle guide may bepositioned or rotated relative to the imaging portion of the imagingconsistent with the planned biopsy locations of the biopsy plan.
 22. Abiopsy needle kit comprising: a flexible stylet containing an extendedspecimen notch; a flexible cannula.
 23. The device of claim 22 wherebysaid stylet and said cannula are manufactured with a pre-formed curvefrom flexible material such as nitinol® or plastic or other suitablyflexible material.
 24. The device of claim 22 whereby said stylet andsaid cannula are manufactured without a pre-formed curve.
 25. The deviceof claim 22 whereby said stylet is assembled from two or more sectionseach made of materials with different properties to improve theflexibility.
 26. The device of claim 22 whereby said cannula isassembled from two or more sections each made of materials withdifferent properties to improve the flexibility.
 27. The device of claim22 whereby the length of said specimen notch is increased to improve theflexibility of the stylet.
 28. The device of claim 22 whereby the crosssection of said stylet is reduced for a portion of the length of thestylet to improve the flexibility of the stylet.
 29. The device of claim22 whereby the cross section of said stylet alternates between areaswhere the cross section is reduced and areas where the cross section isnot reduced to improve the flexibility of the stylet.
 30. The device ofclaim 22 whereby the cannula is spiral cut to improve flexibility. 31.The device of claim 22 whereby the body of the cannula is spiral cut butthe tip of the cannula body is not.
 32. The device of claim 22 wherebythe body of the cannula alternates between spiral cut portions andnon-spiral cut portions.
 33. A redirecting biopsy needle guidecomprising: an opening into which a biopsy needle kit may be inserted;an opening through which a portion of the biopsy needle kit exits; ameans of redirecting said biopsy needle kit such that the portion of thebiopsy needle kit which has exited the biopsy needle guide is angledrelative to the portion of said biopsy needle kit which has not beeninserted into said biopsy needle guide.
 34. The device of claim 33whereby said means of redirecting the biopsy needle physically bends apreviously straight biopsy needle kit.
 35. The device of claim 33whereby said means of redirecting straightens a previously curved biopsyneedle kit such that the biopsy needle kit re-curve when leaving theredirecting means.
 36. The device of claim 33 whereby said means ofredirecting is comprised of one or more static angled or curvedchannels.
 37. The device of claim 33 whereby said means of redirectingis comprised of a movable device such that the opening through which theneedle kit exits may be moved relative to the opening into which thebiopsy needle kit is placed.
 38. The device of claim 33 whereby saidbiopsy needle guide may be affixed to or associated with an ultrasoundor imaging system.
 39. The device of claim 33 whereby said biopsy needleguide may selectively positioned or rotated relative to the imagingportion of the ultrasound or imaging system.
 40. A targeted medicaldeliver mechanism comprising: a flexible delivery means; a flexiblecannula; a redirecting cannula guide; Whereby the cannula can beinserted into specific area of tissue and said delivery means can beinserted through the cannula to said specific area of tissue.
 41. Thedevice of claim 40 whereby said delivery means deposits a material insaid specific area of tissue.
 42. The device of claim 40 whereby saiddelivery means deposits and removes a material in said specific area oftissue.
 43. The device of claim 40 whereby said delivery means removes apreviously-deposited material in said specific area of tissue.
 44. Thedevice of claim 41 whereby said material may be a solid, liquid or gas.45. The device of claim 42 whereby said material may be a solid, liquidor gas.
 46. The device of claim 43 whereby said material may be a solid,liquid or gas.
 47. The device of claim 43 whereby said material may beorganic.
 48. The device of claim 43 whereby said material may be aliving organism.
 49. The device of claim 40 whereby said delivery meansis used to apply energy to said specific area of tissue.
 50. The deviceof claim 49 whereby said energy may be heat, cold, visible ornon-visible radiation.
 51. A biopsy planning and recording meanscomprising: means of receiving and displaying images generated by theimaging means; means of projecting needle image path information ontosaid displayed images; means of recording projected needle pathlocations means of recording actual needle path locations
 52. The deviceof claim 51 whereby said biopsy and planning means can project a linewhich correlates with a needle path.
 53. The device of claim 51 wherebysaid biopsy and planning means can project a dot which correlates to theintersection of the needle path with the imaging plane.
 54. The deviceof claim 51 whereby said projected needle image path information can bepositioned relative to a landmark of the scanned organ or tissue mass.55. The device of claim 51 whereby said projected needle image pathinformation can be correlated to the redirecting guide positioningselection.
 56. The device of claim 51 whereby said biopsy and planningmeans can be used to simulate the insertion of a needle into thetargeted organ or tissue mass.
 57. The device of claim 51 whereby saidreceived images can be used to build a graphical representation of thetargeted organ or tissue mass showing the positions of the projected andactual needle paths relative to the targeted organ or tissue mass. 58.The device of claim 51 whereby said recording projected and actualneedle paths can be recorded to an external medium or transmitted to anexternal location.